(86 days)
MIRACLE 98 is intended for manufacturing: - Porcelain to metal fabrication of single units
MIRACLE 98 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for single unit with lower fusing porcelains and indirect restorative composites. MIRACLE 98 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength, durability and color of gold.
The request is to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.
Based on the provided 510(k) summary for the "MIRACLE 98" dental casting alloy, the device is a Class II device (Gold-based alloys and precious metal alloys for clinical use). The approval is based on substantial equivalence to a predicate device, Heraeous Kulzer's Jel Bios Pure (K002645), rather than a clinical study with acceptance criteria in the typical sense of a diagnostic or AI device.
Here's the information formatted as requested, with "N/A" where the information is not applicable to this type of device and submission:
Acceptance Criteria and Device Performance for MIRACLE 98 (K031010)
This submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Heraeous Kulzer's Jel Bios Pure, K002645) by comparing material composition and physical/mechanical properties. The "acceptance criteria" are implied by the similarity of these characteristics to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Property | Acceptance Criteria (Predicate: Jel Bios Pure) | Reported Device Performance (MIRACLE 98) | Pass/Fail |
|---|---|---|---|
| Composition (Weight %) | |||
| Au (%) | 99.30 | 97.60 | Pass |
| Pt (%) |
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.